—#208441

Product

Braun Thermoscan PRO 6000 Ear Thermometer

FDA product code: FLL — Continuous Measurement Thermometer
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K152748
Affected lot / code info: UDI: 00732094309003 (product code 06000-200) and 00732094309027 (product code 06000-300); All serial numbers.

Why it was recalled

The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).

Root cause (FDA determination)

Process control

Action the firm took

A communication was sent to affected customers via U.S.P.S., first class mail on 06/13/2024. Baxter is asking customers to: 1. Clinicians may continue to use the PRO 6000 ear thermometers according to the current IFU (CD material Number 421032). Please discard all versions of the outdated IFU (material number 419450). The material number is printed on the CD. 2. Acknowledge the receipt of this notification by completing a reply form on the customer portal. UPDATE PER EMAIL DATED 7/24/2024: The firm issued a follow-up letter dated 7/24/2024 via USPS first class mail. The follow-up letter flagged Urgent Medical Device Correction provides the following additional actions to be taken by the customer as a result of the firm expanding the scope of the recall strategy and actions to be taken by the customer: (The content of the other numbered actions remains the same as the initial letter dated 6/13/2024.) 2. Please share this communication with all potential users in your organization and instruct them to follow cleaning instructions in the IFU Maintenance and Service section for proper cleaning. For convenience, the cleaning instructions are summarized in the enclosed Cleaning Guide. 3. Do not use the device if the ring around the measurement button shows a green blinking or flashing light instead of a ready state (solid green light). Contact Baxter Technical Support to report this issue. 4. Do not use the device if the device requires multiple power-ups prior to going to ready state (solid green light). Contact Baxter Technical Support to report this issue. 5. If you experience an overheating probe tip, do not use the device. Contact Baxter Technical Support to report the issue. A Cleaning Guide was enclosed with the letter as well as another response form.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Distributed to United States, Canada, Australia, Malaysia, New Zealand, Philippines, Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, and United Kingdom. UPDATED PER EMAIL DATED 7/24/2024: United States (including Puerto Rico and Guam), Canada, Australia, Brunei, Hong Kong, India, Korea, Malaysia, Maldives, Myanmar, New Zealand, Philippines, Singapore, Taiwan, Thailand, Vietnam, Afghanistan, Austria, Bahrain, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Luxemburg, Namibia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Yemen, Bahamas, Bolivia, Chile, Colombia, Ecuador, Guatemala, Mexico, and Panama.

Timeline

Recall initiated: 2024-06-13
Posted by FDA: 2024-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208441. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.